NDC 50268-086

Atovaquone

Atovaquone

Atovaquone is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Atovaquone.

Product ID50268-086_10fc4532-0b9f-4511-b0a2-bd7edd49cb47
NDC50268-086
Product TypeHuman Prescription Drug
Proprietary NameAtovaquone
Generic NameAtovaquone
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2020-05-07
Marketing CategoryANDA / ANDA
Application NumberANDA210692
Labeler NameAvPAK
Substance NameATOVAQUONE
Active Ingredient Strength750 mg/5mL
Pharm ClassesAntimalarial [EPC], Antiprotozoal [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50268-086-12

20 CUP, UNIT-DOSE in 1 BOX (50268-086-12) > 5 mL in 1 CUP, UNIT-DOSE (50268-086-11)
Marketing Start Date2020-05-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-086-12 [50268008612]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA210692
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-07

NDC 50268-086-11 [50268008611]

Atovaquone SUSPENSION
Marketing CategoryANDA
Application NumberANDA210692
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-07

Drug Details

Active Ingredients

IngredientStrength
ATOVAQUONE750 mg/5mL

NDC Crossover Matching brand name "Atovaquone" or generic name "Atovaquone"

NDCBrand NameGeneric Name
0121-0888AtovaquoneAtovaquone
0121-0898AtovaquoneAtovaquone
0121-1796AtovaquoneAtovaquone
0904-7064AtovaquoneAtovaquone
16714-900atovaquoneatovaquone
31722-629AtovaquoneAtovaquone
50268-086AtovaquoneAtovaquone
51407-642AtovaquoneAtovaquone
60687-534AtovaquoneAtovaquone
65162-693ATOVAQUONEATOVAQUONE
66689-062AtovaquoneAtovaquone
66993-062Atovaquoneatovaquone
68180-282AtovaquoneAtovaquone
68462-421atovaquoneatovaquone
70166-488AtovaquoneAtovaquone
10702-223Atovaquone Oral SuspensionAtovaquone
0173-0547MEPRONatovaquone
0173-0665MEPRONatovaquone
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